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Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05286554
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
12.1
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. There are many protocols of luteal phase support (LPS) in assisted reproductive technology (ART) cycles. GnRH-agonist (GnRH-a) is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. If the GnRH-a is administered in the mid-luteal phase, an initial flare-up with increased levels of LH takes 3-4 days before receptor down-regulation kicks in. The increased luteinizing hormone (LH) results in increased support for the corpus luteum (CL), leading to higher output of P4 and providing stronger LPS. In earlier studies, the inadvertent administration of GnRH-a in the mid-luteal phase, did not compromise pregnancy outcomes but rather enhanced implantation rates. Therefore, the use of GnRH-a in LPS was investigated and found to enhance clinical outcomes after GnRH-a and GnRH antagonist- treated ovarian stimulation cycles, as well as, in recipients of donated oocytes. Several studies since then investigated the role of GnRHa for LPS, found that luteal support with GnRH-a could be used as the first choice in patients at high risk for ovarian hyperstimulation syndrome (OHSS), or even as the sole source of LPS in a GnRH-a-triggered antagonist ovarian stimulation cycle. Although many trials have showed substantial efficacy of GnRH-a addition for luteal support on pregnancy outcomes in women undergoing IVF/ICSI, others, found no benefit of its addition to the standard LPS. A meta-analysis concluded that there is benefit, however, this evidence is of very low quality. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles
Actual Study Start Date :
Mar 17, 2022
Anticipated Primary Completion Date :
Dec 17, 2022
Anticipated Study Completion Date :
Mar 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Will receive routine LPS and additional single GnRH-a bolus, triptorelin 0.1 mg subcutaneous injection on the 6th day after oocyte retrieval.

Drug: gonadotropin releasing hormone-agonist
subcutaneous injection
Other Names:
  • triptorelin 0.1 mg

    • Drug: Progesterone
    vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
    Other Names:
  • cyclogest

    		•
    Experimental: Group 2

    Will receive routine LPS and additional multiple mid-luteal GnRH-a, triptorelin 0.1 mg subcutaneous injection on the 5th, 7th and 9th days after oocyte retrieval.

    Drug: gonadotropin releasing hormone-agonist
    subcutaneous injection
    Other Names:
  • triptorelin 0.1 mg

    • Drug: Progesterone
    vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
    Other Names:
  • cyclogest

    		•
    Active Comparator: Group 3 (Control)

    Will receive the routine LPS without GnRH-a

    Drug: Progesterone
    vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
    Other Names:
  • cyclogest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [2 weeks after positive pregnancy test]

      Calculated as the number of clinical pregnancies (Presence of an intrauterine gestational sac with embryonic cardiac activity observed by vaginal ultrasound) divided by the number of embryo transfer procedures.

    Secondary Outcome Measures

    1. Implantation rate [2 weeks after positive pregnancy test]

      the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred.

    2. Multiple pregnancy rate [8 weeks of gestation]

      The percentage of pregnancies with more than one fetus

    3. Serum β-human chorionic gonadotropin (β-HCG) concentration [15 days after ICSI]

      In milli-International unit/ml on day 15 after ICSI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient age ≤ 38 years.

    2. BMI ≤ 30.

    3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.

    4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.

    Exclusion Criteria:

    1. Endometriosis.

    2. Polycystic ovarian syndrome (PCOS).

    3. Uterine pathology or anomaly.

    4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound.

    5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Alexandria Egypt 21526

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    • Principal Investigator: Mervat Sheikh El-arab, PhD, Alexandria Univsersity
    • Study Director: Ahmed Abdel Aziz, PhD, Alexandria Univsersity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05286554
    Other Study ID Numbers:
    • 0201599
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alexandria University
    luteal phase support, ICSI, gonadotropin releasing hormone agonist
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Triptorelin Pamoate
    Hormones
    Progesterone

    Study Results

    No Results Posted as of Apr 6, 2022